Z-1071-2012

Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet...

Name: Z-1071-2012 Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet...
Creator: Biomet, Inc.
Published: 2011-12-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-12-14 / Terminated

FDA source

Biomet, Inc. began a recall of Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. Intended for primary and... on 2011-12-14. The reason FDA records is "A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1071-2012
Status: Terminated
Initiated: 2011-12-14
Posted: 2012-02-21
Terminated: 2012-12-12
Recalling firm: Zimmer GmbH
Product: Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. Intended for primary and revision joint arthroplasty for use in cemented applications.
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
FDA root cause: Process change control
Action: December 14, 2011 Urgent Medical Device Recall Notices were sent to Distributors and hospital OR managers describing the product, problem, risks associated with the recall, and actions to be taken. The notice included Instructions to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, prior to returning product by priority mail to the attention of Angi Dickson, Biomet , 56 East Bell Drive Warsaw, IN, USA 46580 with a copy of the response form. Receipt of the notice should also be confirmed by calling 800-348-9500, extension 3983 or 3009. Questions related to this notice should be directed to 574-371-3983 or 574-371-3009 Monday through Friday 8 AM to 5 PM.
Quantity in commerce: 10 units
Distribution: International Only Distribution -- Netherlands & UK.
Product codes and lots: REF 114700, Lot 797550

Product code JDC

K051975Class IIPorous Coated Discovery ElbowBiomet, Inc. / cleared 2005-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)